Device features and design elements for long-term adhesion

ABSTRACT

An electronic device for long-term adhesion to a mammal includes a housing with an electronic component. The electronic device may include a first wing and a second wing, each being integrally formed with the housing. An electrode is positioned on a bottom surface of each of the wings, the electrodes electrically connected to the electronic component. An adhesive layer is provided for adhesion to a surface of the mammal. The adhesive layer may cover a portion of the bottom surfaces of the wings but generally does not cover the electrode or a bottom surface of the housing. A method of applying an electronic device to a mammal includes removing first and second adhesive covers from first and second wings of the electronic device to expose an electrode and an adhesive coated on a bottom surface of each wing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/723,208, filed Dec. 20, 2019, titled “Device Features and DesignElements for Long-Term Adhesion” which claims priority to U.S.application Ser. No. 16/138,819, filed Sep. 21, 2018, titled “DeviceFeatures and Design Elements for Long-Term Adhesion” which claimspriority to U.S. application Ser. No. 15/005,854, filed Jan. 25, 2016,titled “Device Features and Design Elements for Long-Term Adhesion”which claims priority to U.S. application Ser. No. 13/890,144, filed May8, 2013, titled “Device Features and Design Elements for Long-TermAdhesion” which claims priority to U.S. application Ser. No. 13/563,546,filed Jul. 31, 2012, titled “Device Features and Design Elements forLong-Term Adhesion”, which claims priority to U.S. patent applicationSer. No. 13/106,750, filed May 12, 2011, which claims priority to U.S.Provisional Patent Application Ser. No. 61/334,081, filed May 12, 2010,entitled “Device Features and Design Elements for Long-Term Adhesion.”All of the aforementioned applications are incorporated by reference asif fully set forth herein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

This application relates to devices worn on a body for monitoring,recording, reporting and/or treating the person wearing the device.Improvements in the device design elements and functionality aredisclosed for maintaining the device in contact with and operational forextended periods of time, typically longer than 24 hours.

BACKGROUND OF THE INVENTION

The ability to adhere a medical device to a human body for a long-periodof time is dependent on a variety of factors. In addition to the typeand nature of the adhesive chosen, another factor is the mechanicaldesign of the device. By design, this refers to, but is not limited to,the device shape, size, weight, flexibility, and rigidity. These designelements are influenced by a number of additional factors, including,hut not limited to, where on the body the device will attach and theduration of the attachment, moisture conditions in that area, movementconditions in that area, stretching and contraction in that area,interactions with external factors in that area such as clothing, andpurposeful and/or inadvertent interaction between the person wearing thedevice and the device.

As many are typically used on the body for less than 24 hours, deviceshave not been designed that can withstand longer-term adhesion. Hence,there is a need to implement device features and design elements thathave the ability to enhance the likelihood of adhesion of a device to ahuman body for 24 hours or more, while accommodating the functionality,shape, size, weight, flexibility, and rigidity of a given device.

SUMMARY

In one aspect of the invention, there is an electronic device forlong-term adhesion to a mammal. The device has a housing containing anelectronic component with a first wing and a second wing integrallyformed with the housing. There is an electrode positioned on a bottomsurface of each of the wings with the electrodes electrically connectedto the electronic component. An adhesive layer is provided tor adhesionto a surface of the mammal. The adhesive layer is coated on a portion ofthe bottom surface of the wings. The adhesive layer is not coated on theelectrode or on a bottom surface of the housing.

The electronic component in any of the devices described herein mayinclude a processor having a memory with computer readable instructionsto record signals from the first and second electrodes while theelectronic device is attached to the mammal. The processor may beconfigured to only convert signals from the electrodes to digitalsignals, filter those signals and then store the signals in memory.

In another aspect, the device includes a flap connected to each of thewings. The flaps may extend below the housing. Additionally oralternatively, the adhesive layer is coated on a bottom surface of theflaps.

In another aspect, the device includes a connector segment In oneaspect, the connector segment configured to connect the flaps together.In other aspects, the connector segment is located at least partiallybelow the housing. Still further, the connector segment is not attachedto the housing.

In one alternative, the adhesive layer is coated on a bottom surface ofthe flap.

In still another aspect, the adhesive for adhesion to a surface of themammal is an adhesive that can absorb fluids. In another aspect, theadhesive that can absorb fluids is a hydrocolloid adhesive. In anotheraspect, the adhesive for adhesion to a surface of the mammal is apressure-sensitive adhesive. The pressure sensitive adhesive is selectedfrom the group consisting of: a polyacrylate, a polyisobutylene, and apolysiloxane. In one alternative, the device includes a diffusionbarrier between the adhesive layer and each of the wings. The device mayalso include an additional adhesive layer and material layer between thewing and the adhesive layer for adhesion to the mammal. The materiallayer is configured to prevent diffusion of adhesive components from theadhesive layer to the wing. The diffusion barrier may be made frompolyester or other suitable synthetic material.

In one aspect of the device, all or substantially all of the electroniccomponents are within the housing. In another aspect, the wing is freefrom electronic components. In one aspect, the wing is more flexiblethan the housing. In one alternative, the wings and the housing are madefrom the same material. In another aspect, the wings and the housing aremade from different materials. In another, the wings are made from afabric. In still another aspect, the material used to make the wingsincludes a synthetic fiber. In another alternative, the wing and theflap are composed of the same material.

In another alternative, the device includes a hinge portion between thehousing wmg, The hinge portion is configured to allow the device to bendbetween the housing and the wmg. In one aspect, the hinge portion existsbetween a rigid portion of the device and a flexible portion of thedevice. In one alternative, the rigid portion of the device correspondsto the portion of the housing including the electronics and the flexibleportion of the device includes a wmg

In one aspect, the bottom surface of the wing and the bottom surface ofthe flap are contiguous, In another aspect, the bottom surfaces of thewings, the flap, and the connectors are contiguous. In still otheraspects, the flaps and the connector are contiguous.

In another aspect, the connector has at least one hole extending it. Thehole may have any of a number of shapes such as circular, oval, round,or triangular.

In one aspect, the housing is thicker at a center of the housing than atedges of the housing.

In another aspect of the device, the housing is unattached to the mammalwhen the electrodes are in contact with the mammal.

In another alternative aspect of a device for long-term adhesion to amammal, the device includes a housing with a first wing extendinglaterally from the housing and a second wing extending laterally fromthe housing without overlapping the first wing, There is a firstelectrode positioned on a bottom surface of the first wing and a secondelectrode positioned on a bottom surface of the second wing. Anelectronic memory is positioned within the housing. The electronicmemory is configured to receive and store electronic signals from thefirst and second electrodes while the electronic device is attached tothe mammal. There is also an adhesive layer on a portion of a bottomsurface of the first wing and the second wing. The adhesive is not on abottom surface of the housing. When the device is worn on the mammal,only the adhesive layer(s) are attached to the mammal.

In one aspect, the portion of the bottom surface of the first wing andthe second wing does not include the first and second electrodes, In onedevice aspect, the first wing, the second wing, and the housing areformed from the same material. In still another, the first wing, thesecond wing and the housing integrally form a monolithic structure. Inother aspects, an angle formed by the first wing, the second wing, andthe housing is between approximately 90° and 180°, In one variation, theangle is approximately 180°, In another variation, the angle isapproximately 135°.

In still other embodiments, there is a first hinged portion between thefirst electrode and the processor and a second hinged portion betweenthe second electrode and the housing.

In a further aspect, at least a portion of the body uncovered is notadhered to the mammal when signals from the electrodes are beingrecorded in memory.

In another aspect, the device includes a first flap connected to thefirst wing medial to the first electrode and a second flap connected tothe second wing medial to the second electrode. Each nap may extendbelow the housing.

The device may also include a connector segment configured to connectthe flaps together. In one aspect, the connector segment is located atleast partially below the housing, but is not attached to the housing.

In another aspect, there is an electronic device that has a patchincluding a housing containing an electronic component. There is anelectrode positioned on a bottom surface of the patch, the electrodeelectrically connected to the electronic component. There is a firstadhesive strip extending around the perimeter of the patch and a secondadhesive strip extending around the perimeter of the first adhesivestrip, In one aspect, the first adhesive cover over the first adhesivestrip and a second adhesive cover over the second adhesive strip, Thefirst and second adhesive covers may be configured to be separablyremoved from the first and second adhesive strips, In one alternative,the first adhesive strip extends between the first and second adhesivecovers. In another alternative, the adhesive in the first and the secondadhesive strips is an adhesive that can absorb fluids. In still anotheraspect, the adhesive that can absorb fluids is a hydrocolloid adhesive.In one alternative, the adhesive in the first and the second adhesive isa pressure-sensitive adhesive. In some aspects, the pressure-sensitiveadhesive is a polyacrylate, a polyisobutylene, or a polysiloxane.

In one alternative, the second adhesive strip partially overlaps thefirst adhesive strip. In another aspect, the second adhesive strip isattached to a shell, the shell overlapping the first adhesive strip.

In still another alternative device for long-term adhesion to a mammal,the device includes a patch having a housing with an electroniccomponent contained therein, There is an electrode positioned on abottom surface of the patch, The electrode electrically connected to theelectronic component There is a porous foam pad configured to hepositioned between the electronic component and the mammal. In oneaspect, the porous foam pad comprises a biocompatible foam material. Inone variation, the porous foam pad can absorb fluids. In still anotheraspect, the porous foam pad is attached to the housing. In another, theporous foam pad is configured to be attached to the mammal. In anotherrequest, the porous foam pad can absorb fluids.

In one aspect of a method of applying an electronic device, there is astep of removing a first adhesive cover from the first wing of theelectronic device to expose an electrode and an adhesive coated on abottom surface of a first wing, There is a step of placing the exposedelectrode into contact with the mammal by adhering the adhesive coatedbottom of the first wing to the mammal. There is also a step of removinga second adhesive cover from the second wing of the electronic device toexpose an adhesive coated on a bottom surface of the second wing andanother exposed electrode, There is also a step of placing the anotherexposed electrode into contact with the mammal by adhering the adhesivecoated bottom of the second wing to the mammal. After performing theremoving and the placing steps, the housing is unattached to the mammal,but is held in position on the mammal using the adhesive coated bottomsof the first and the second wings.

In one alternative method of attaching a device, the electronic deviceincludes a first nap connected to the first wing and a second flapconnected to the second wing. The first and second flaps each extendbelow the housing. The step of removing a first adhesive cover from thefirst wing may also include exposing an adhesive coated on a bottomsurface of the first flap. The step of removing a second adhesive coverfrom the second wing may also include exposing an adhesive coated on abottom surface of the second flap.

In another alternative method of attaching a device, after performingthe removing and the placing steps, the housing is held in position onthe mammal using only the adhesive coated bottoms of the first wing, thesecond wing, the first flap and the second flap.

In an alternative aspect of a method of applying an electronic device toa mammal for long-term adhesion, the method includes removing a firstadhesive cover from the first wing of the electronic device to expose anelectrode and an adhesive coated on a bottom surface of the first wing.There is also a step of removing a second adhesive cover from the secondwing of the electronic device to expose an adhesive coated on a bottomsurface of the second wing and another exposed electrode. There is astep of placing the exposed electrodes into contact with the mammal byadhering the adhesive coated on the bottom of the first and the secondwings to the mammal, After performing the removing and the placingsteps, the housing is unattached to the mammal, but is held in positionon the mammal using the adhesive coated bottoms of the first and thesecond wings.

There is also provided a method of applying an electronic device to amammal for long-term adhesion wherein the electronic device includes apatch. The patch includes an electronic component along with anelectrode positioned on a bottom surface of the patch and electricallyconnected to the electronic component. There is a first adhesive stripextending around the perimeter of the patch and a second adhesiveextending around the perimeter of the first adhesive strip. One aspectof a method of applying the device includes a step of removing anadhesive cover from the second adhesive strip of the electronic device.There is a step of applying pressure to the second adhesive strip toadhere the second adhesive strip to the mammal such that the electrodeis in contact with the mammal. Then, after a period of time, removing anadhesive cover from the first adhesive strip of the electronic device.Next, there is the step of applying pressure to the first adhesive stripto adhere the first adhesive strip to the mammal such that the electroderemains in contact with the mammal.

In another alternative method of applying an electronic device to amammal for long-term adhesion, the electronic device includes a patch,an electronic component, and an electrode positioned on a bottom surfaceof the patch and electrically connected to the electronic component.There is a first adhesive strip extending around the perimeter of thepatch. The method includes a step of applying pressure to a firstadhesive strip to adhere the first adhesive strip to the mammal suchthat the electrode is in contact with the mammal. After a period oftime, placing a second adhesive strip around the perimeter of the firstadhesive strip. Then there is the step of applying pressure to thesecond adhesive strip to adhere the second adhesive strip to the mammalsuch that the electrode remains in contact with the mammal.

Any of the above described devices may include additional aspects. Adevice may also include a first wire connecting the first electrode andthe processor or an electronic memory and a second wire connecting thesecond electrode and the processor or an electronic memory. The firstand second wires extend within the body and the first and second wings.In one aspect, the first and second wires extend within and arecompletely encapsulated within the body and the first and second wings.In one aspect, a conduit is provided within the body and the wings andthe wires pass through the conduit. In one alternative, the conduitextends from the processor or electronic memory to an electrode so thatthe wire is completely within the conduit. In still other aspects of thedevices described above, the first and second wires connecting theelectrodes to the processor or electronics each include slack betweenthe electrode and the processor. In one aspect, the slack is located ina portion of each wing that is configured to bed or flex. In anotheraspect, the slack is a portion of the wire within the wing and at leastpartially coiled about the first or the second electrode. In still otheraspects, the slack is provided by a portion of the wire formed into acoil, a wave pattern, or a sinusoidal pattern along its length theconnection point on the electronics to the connection point on theelectrode.

In still other alternatives, the devices described above may be appliedto any of a wide variety of conventional physiological data monitoring,recording and/or transmitting devices. Any of the improved adhesiondesign features and aspects may also be applied to conventional devicesuseful in the electronically controlled and/or time released delivery ofpharmacological agents or blood testing, such as glucose monitors orother blood testing devices. Additional alternatives to the devicesdescribed may include the specific components of a particularapplication such as electronics, antenna, power supplies or chargingconnections, data ports or connections for down loading or off loadinginformation from the device, adding or offloading fluids from thedevice, monitoring or sensing elements such as electrodes, probes orsensors or any other component or components needed in the devicespecific function. In still other aspects, the electronic component inany of the above devices is an electronic system configured forperforming, with the electronic signals of the mammal detected by theelectrodes, one or more or any combination of or the followingelectronic functions: monitoring, recording, analyzing, or processingusing one or more algorithms electronic signals from the mammal. Stillfurther, any of the devices described above may include appropriatecomponents such that the device is used to detect, record, process ortransmit signals or information related to signals generated by a mammalto which the device is attached including but not limited to signalsgenerated by one or more of EKG, EEG and/or EMG.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a top view of a patch having two wings;

FIG. 1A is a representative cross-section of an embodiment of the patchin FIG. 1;

FIG. 1B is a representative cross-section of another embodiment of thepatch in FIG. 1;

FIG. 1C is a representative cross-section of another embodiment of thepatch in FIG. 1;

FIG. 1D is a representative cross-section of another embodiment of thepatch in FIG. 1;

FIG. 1E is a representative cross-section of another embodiment of thepatch in FIG. 1;

FIG. 1F is a top view of a patch having three wings illustrating analternative electrode-electronics-electrode orientation;

FIG. 2A is a schematic drawing of the electronics contained within apatch;

FIG. 2B is a schematic drawing of a patch with wiring having slack inthe form of undulations between electronics and electrodes;

FIG. 2C is a schematic drawing of a patch with wiring having slack inthe form of a coil between electronics and electrodes;

FIG. 3 is the bottom view of a patch having adhesive thereon;

FIG. 4A shows a patch as worn by a person rolled to the side;

FIG. 4B shows a patch as worn by a person playing golf;

FIG. 5A shows a patch in response to a concave bend of the skin;

FIGS. 5B and 5C show a patch in response to a convex bend of the skin;

FIG. 6A is a bottom view of a patch having a connector between twoflaps;

FIG. 6B is a cross-section of the patch of FIG. 6A;

FIG. 7A is a bottom view of a patch having multiple covers formingstrips of adhesive;

FIG. 7B is a cross-section of the patch of FIG. 7A;

FIG. 8A is a bottom view of a patching having multiple covers formingstrip of adhesive around each electrode;

FIG. 8B is a cross-section of the patch of FIG. 8A;

FIGS. 9A and 9B show a patch having multiple layers formed thereon;

FIGS. 10A and 10B show a patching having multiple layers formed thereon,each layer having multiple patches of adhesive;

FIG. 11 shows a patch having an open cell support;

FIG. 12 shows a patch having an annular open cell support;

FIG. 13A shows a patch having a protective shell thereon; and

FIG. 13B shows a cross-section of the patch of FIG. 13A.

DETAILED DESCRIPTION

The following device features and design elements can be implementedinto any device being adhered to the human body for a long-period oftime, typically greater than 24 hours. As an example, the followingdevice features and design elements can be used for long-term adhesionof a cardiac rhythm monitoring patch (“patch”) to the chest of a person.

Referring to FIGS. 1 and 1A, a patch 100 for long term adhesion includesa housing 102. The housing 102 can be formed from any flexible, durablematerial, such as a biocompatible polymer, for example silicone. Thehousing 102 can include electronic components 108 therein. As shown inFIG. 2, the electronics 108 can include a printed circuit board 220, abattery 225, and a communications port mounted on the printed circuitboard 220. The printed circuit board 220 can include analog circuits210, digital circuits 215, and an activation or event notation button orswitch 130. The electronics 108 can be used, for example, to recordcontinuous physiological signals from a mammal wearing the patch 100. Asystem for continuously recording data is described further in co-ownedU.S. application Ser. No. 11/703,428, filed Feb. 6, 2007, the entirecontents of which are incorporated by reference herein.

As shown in FIGS. 1 and 1A, wings 104, 106 can be connected to thehousing 102. The wings 104, 106 can be integral with the housing 102and, in some embodiments, can be formed of the same material as thehousing 102. The wings 104, 106 can be more flexible than the electroniccomponents 108, which can be substantially rigid. An electrode 124, 126can extend through a bottom surface of each wing 104, 106. Theelectrodes can be positioned to detect an ECG of a mammal wearing thepatch 100 for processing by the electronics 108. For example, theelectrodes can be more than 2 cm apart, such as more than 3 cm apart,for example at least 6 cm apart. The electrodes 124, 126 can be integralwith the wings 104, 106 so as to be inseparable from the wings 104, 106when the patch is in use.

For a patch 100 that is entirely flexible and can conform, stretch, andadapt to the movement and conditions of the chest underneath the device,adhesive can be placed over the entire surface of the device that is incontact with the body, except for areas where sensors, electronics, orothers elements such as electrodes are interacting with the body relatedto the functioning of the device may be incorporated. Thus, as shown inFIG. 3, an adhesive layer 166 can coat the bottom of the patch 100 torattachment to the skin, For a patch 100 in which there may be some areasthat are not completely flexible and may not be able to stretch orcontract (e.g., the electronics 1(8), adhesive may be excluded from theportion of the patch 100 underneath these areas. Thus, for example, thebottom surface 302 of the housing 102, which contains the electronics,can remain free from adhesive. As shown in FIG. 1A, by not coatingadhesive on a bottom surface of the housing 102, the housing 102 canfloat above the adhered portions, allowing for increased flexibility ofthe patch, as will be discussed further below. Further, as shown in FIG.3 the bottom surface of the electrodes 124, 126 can remain free ofadhesive. For example, a ring 362 without adhesive can be formed aroundeach electrode 124, 126 to separate the electrodes from the adhesive164, The adhesive can be, for example, a pressure-sensitive adhesive,such as polyacrylate, polyisobutlene, or a polysiloxane. Alternatively,the adhesive can be a hydrocolloid which advantageously absorbs water.

The wings 104, 106 and the housing 102 can form a smooth, contiguousouter surface to the patch 100, As shown in FIG. 1A, when viewed fromthe top, the housing 102 and wings 104, 106 can together form an oblongsubstantially oval shape, Further, the housing 102 can have a thicknessthat is greater than the thickness of the wings 104, 106. The housing102 and each of the wings 104, 106 when viewed in profile, can each forma dome with a height that is greater at the center than at the ends ofthe respective component, i.e. some or all of the components can betapered at the ends and/or sides.

The electronics 108 can extend along only a portion of the distancebetween the electrodes 104, 106. For example, the electronics can occupyless than 90% of the distance between the electrodes, for example lessthan 80%. By having the electronics 108 in a relatively limited spacebetween the electrodes 124, 126, the flexibility of the patch 100 can beincreased

The housing 102 can provide a watertight enclosure 110 for electroniccomponents 108 of the patch 100, The electronics 108 can be unattachedto the housing 102 such that the electronics 108 are free to move withinthe watertight enclosure 110. Allowing the relatively rigid electronics108 to move freely within the flexible housing 102 advantageouslyenhances the overall flexibility of the patch 100, The wings 104, 106can each have a watertight enclosure 114, 116 formed therein, which canbe contiguous with the watertight enclosure 110 of the housing 102.

Wiring 120 or other suitable electrical connections can connect theelectrodes 124, 126 with the electrical components 108 of the housing.In some embodiments, as shown in FIGS. 1B-1E, the contiguous nature ofthe enclosure 110 and the enclosures 114, 116 allows the wiring 120 toextend within the patch 100 from the electrodes 124, 126 to theelectronic components 108. In other embodiments, one or more channels,tubes, or conduits are provided between the housing 102 and the wings104, 106, to provide space for the wiring 120. The tube or channel maybe straight or curved. In use, the wire 120 positioned in the enclosures110, 114, 116 or in the tube or channel may move relative thereto inorder to remain flexible within the housing. In one aspect, the flexiblechannels or tubes are formed within the device housing so that thehousing, as it is being stretched, does not affect the ability of thecomponents, such as wires, that may connect more rigid structures, tomove or elongate.

As shown in FIG. 1, the wire 120 is straight with a direct line ofconnection between the electrodes 124, 126 and the electronics 108. FIG.1 illustrates an embodiment where the length of the wires 120 connectingthe electrodes 124, 126 to electronics 108 are about the same distanceas the spacing between the electrode connection point on electronics 108and the electrodes 124, 126. FIG. 1F also illustrates a straight linetype connection where wire 120 length is nearly the same as the spacingbetween the electronics 108 and the electrodes 124, 126. However, as apatient moves, the patch 100 flexes along with patient movement. Asshown in FIGS. 4B and 5C, patch flexion may be severe and is likely tooccur during long term monitoring. In order to address the possibledislocation or breakage of the wire 120, the length or shape of the wire120 may be selected to permit patch flexion to occur with little risk ofwire 120 pulling from the electrode or electronics. Numerousalternatives are possible to compensate for patch flexion. Exemplaryconfirmations include undulations or zig-zags 231 as shown in FIG. 2B,coils 233 as shown in FIG. 2e , or a configuration that partially orfully wraps around an electrode. In some embodiments, other components,such as the circuit hoard or electrodes, can alternatively oradditionally contain additional length to help accommodate stretch ordisplacement. When the patch 100 is attached to a mammal, the slack inthe wiring 120 allows the patch 100 to flex while not placing stress onthe wiring 120.

While the illustrated embodiments of FIGS. 1A-1D show only two wings andshow the electrodes and electronics in a direct line in a approximate180 degree alignment of electrode 124 to electronics 108 to electrode126), other configurations are possible. For example, as shown in FIG.1F, the wings 104, 106 are arranged in an orientation less than 180degrees. In the illustrated embodiment, the angle formed by theelectrodes and the electronics is about 135 degrees. Other ranges arepossible so long as electrode spacing is provided to permit ECGmonitoring. The orientation of the wings 104, 106 to the housing 102also illustrates the use of an additional adhesive tab 105. Tab 105 isshown as a semicircular extension of the body 102. The bottom of tab 105can include adhesives as described herein and is used to provideadditional anchoring of the patch to the patient. The tab 105 may beformed in any of a number of different shapes such as rectangles, ovals,loops or strips. Further, in some embodiments, the tab 105 can functionsimilar to a wing, e.g., include an electrode therethrough that connectsto the electronics 108.

Referring to FIGS, 1A-1D and 2B-2C, a hinge portion 194,196 in the patch100 can extend between each electrode 124, 126 and the electronics 108.The hinge portions 194, 196 can have a thickness less than the thicknessof surrounding portions of the patch 100, For example, if the hingeportions 194, 196 are in the wings 104, 106, then the thickness can beless than adjacent portions of the wings. Likewise, the hinge portions194, 196 can have a width less than adjacent portions of the patch 100,e.g., less than adjacent portions of the wings 104, 106. Alternatively,the hinged portion can be formed by the adjunct between a rigid portion,i.e. the electronics 108, and a more flexible portion, The hingedportion allows the patch 100 to bend between the housing 102 and wings104, 106 to compensate for any movement caused by the patient. As shownin FIGS. 2B and 2C, the slack in the wiring 120 can be placed at orproximal to the hinge portions 194, 196 to allow for bending at thehinge portions 194, 196 without pulling or breaking the wiring 120.

Referring to FIGS. 4A and 4B, having adhesive on the bottom of the patch100 except in the areas substantially around the electrodes and directlyunderneath the housing 102 can create a floating section 455 over theskin of the mammal to which the patch 100 is attached. The floatingsection 455 can house the more rigid or less flexible electroniccomponents while the flexible wings 104, 106 can be adhered to the skinand provide the flexibility necessary to hold the patch 100 in place. Asa result of this selective use of adhesive areas and non-adhesive areas,the limitation on device flexibility imposed by the less flexiblefloating section can he mitigated or reduced by hounding the floatingsection with one or more adhered flexible areas. The flexible sectionscan thus adhere to the body if the underlying portion of the body isstretched and/or contracted while the floating section is free to moveabove the skin, for example if the person wearing the device rolls over(as shown in FIG. 4A) or is involved in activities that can otherwisecause movement of the skin (as shown in FIG. 4B).

Referring back to FIGS. 1B-1E, each wing 104, 106 can include a materiallayer 214, 216 between the adhesive 164, 166 and the wings 104, 106, Thematerial layer 214, 216 can be, for example, a polyester layer. Thematerial layer 214, 216 can be attached to the patch 100 with a layer ofadhesive 204, 206, The adhesive 204, 206 can be the same as the adhesive164, 166 or different. For example, the adhesive 204, 206 could be asilicone adhesive. The material layer 214 can serve as a barrier toprevent diffusion or migration of adhesive components, such as atackifier, from the adhesive 164, 166 into the wings 104, 106 or housing102. The material layer 214 can thus advantageously serve to maintainthe strength of the adhesive 104, 106 over time.

Referring still to FIGS. 1B-1E, the patch 100 can further include afirst flap 154 connected to the first wing 104 and a second flap 156connected to the second wing 106. The flaps 154, 156 can both extendfrom a position on the wings 104, 106 medial to the electrodes to aposition below the housing 102, such as below the electronics 108. Theflaps 154, 156 can remain unattached to the housing 102. As a result,gaps 144, 146 can be formed between the flaps 154, 156 and the housing102. The gaps can provide additional “floating” for the housing 102 andthe relatively rigid components 108 contained therein.

In some embodiments, shown in FIG. 1B, the flaps 154, 156 can beattached to the wings 104, 106 with adhesive 134, 136. The adhesive 134,136 can be the same as the adhesive 164, 166 or different. For example,the adhesive 134, 136 could be a silicone adhesive. In otherembodiments, shown in FIGS. 1C-1E, the flaps 154, 156 can be integralwith the wings 104, 106. For example, the flaps 154, 156 can be solventwelded to and/or formed during the molding process of the wings 104, 105such that hinges 194, 196 form below the wings 104, 106. Additionally oralternatively, one or more of the flaps 154, 156 may be separablyattached to the wings 104, 106. In some embodiments, shown in FIGS. 1Band 1C, the materials making up the flaps 154, 156 can extend all theway to the lateral edge of the patch 100. In other embodiments, shown inFIG. 1D, a flap can extend on each side of the electrodes, i.e. one flapcan extend medially and the other laterally. In some embodiments, thelateral and medial-extending flaps are part of the same annular flap. Inother embodiments, shown in FIG. 1E, the flaps and materials making upthe flaps extend only from a position medial to the electrodesunderneath the housing.

The Flaps 154, 156 may be positioned in virtually any relationship tothe adhered flexible area such that, when attached in use, theattachment of the flap or flaps effectively counteracts the expectedexternal forces acting on the device, specifically those forces that maydislodge the adhered flexible areas. Further, in embodiments such asthat shown in FIG. 1F where there are more than two wings, there can bea flap corresponding to each additional wing.

The adhesive layers 164, 166 can coat all or a portion of the bottom ofeach of the flaps 154, 156. In some embodiments, the adhesive 164, 166extends continuously from the bottom surface of the wings 104, 106 tothe bottom surface of the flaps 154, 156, except for areas proximate tothe electrodes 124, 126. Further, the top surface of the flaps 154, 156,i.e. the surface closest to the housing 102, can remain free of adhesiveto ensure that the housing 102 remains floating. In some embodiments,the only portion of the patch 100 including adhesive for adhesion to theskin can be the flaps 154, 156.

Referring to FIGS, 5A-5C, the naps 154, 156, can provide hinge-likebehavior for the patch 100, Thus, as shown in FIG. 5A, if the skin 501is stretched or bent in a concave manner, the gaps 144, 146 between theflaps 154, 156 and the housing 102 can approach zero such that the patch100 can sit substantially flat on the skin 501. As shown, the hingeportions 194, 196 between the housing 102 and wings 104, 106 can provideadditional flexibility for concave bends by flattening as the patch 100is stretched. In contrast, as shown in FIGS. 5B and 5C, as the skin 501is bent in an increasingly convex manner, the gaps 144, 146 between theflaps 154, 156 and the housing 102 can increase, thereby allowing theflexible wings 104, 106 to remain adhered to the skin and the rigidhousing 102 to float above skin. As shown, the hinge portions 194, 196between the housing and the wings 104, 106 can provide additionalflexibility for convex bends by folding inward as the patch 100 is bent.

When placed substantially flat on the skin 501, the patch 100 can have aheight that extends no more than 2 cm off of the skin, such as no morethan 1.5 cm off of the skin, when lying flat on the patient and no morethan 4 cm, such as no more than cm off of the skin when floating abovethe skin. The relatively low height of the patch 100 can enhancelong-term adhesion by reducing the potential for the patch] 00 to snagor rip off of the skin.

Advantageously, the flaps 154, 156 can function as anchors for adhesionthat mitigates shear force. The flaps 154, 156 can provide a differentdirection for the acute and chronic forces being experienced by thedevice due to stretching, contraction, or torsion to be spread out overboth the flap as well as the flexible adhesive areas. Further, bypre-aligning the orientation of the floating section, adhered flexiblearea and the flaps, the device may be better able to tolerate (i.e.,remain attached to the body and in use) and/or tailor the interactionwith the forces acting on the device in order to better withstand theacute or chronic forces being experienced by the device. Tailoring theresponse of the device to the expected forces is one

Because the flaps can be used to counteract forces acting on aparticular device, it is to be appreciated that the dimensions,flexibility, attachment technique, and/or orientation between a flap andanother component may vary depending upon the purpose of a particularflap. Accordingly, a flap may have the same or different characteristicsfrom another flap or component of the device. In one aspect, at leastone flap is more flexible that the other flaps in a particular device.In another aspect, each of the flaps has similar flexibility. In stillanother aspect, at least one flap is more flexible than the devicecomponent to which it is attached or from which it originates. In stillanother aspect, at least one flap is less flexible than the devicecomponent to which it is attached or from which it originates.

Referring to FIGS. 6A and 6B, in one embodiment, the flaps 154, 156 maybe augmented by a connector segment 607 used to join the flaps together.The connector segment 607 can extend below the housing 102, but remainunattached to the housing 102. As shown in FIG. 6A, the flaps 154, 156and the connector 607 can together form a butterfly shape. In oneembodiment, the connector segment 607 and the flaps 154, 156 are formedfrom a single piece of material. The connector segment 607 can be madeof the same material as the flaps 154, 156 or of different material. Inone embodiment, the bottom surface of the connector is covered withadhesive. In another embodiment, the bottom surface of the connectordoes not include any adhesive. Further, as shown in FIG. 6B, theconnector segment 607 can be thicker in the middle, under the housing102, than near the edges, i.e., closer to the electrodes. The variablethickness can help prevent the connector segment 607 from capturingmoisture thereunder. The connector segment 607 can advantageouslyprevent the device from flipping when attached to the patient

The connector segment 607 can include one or more holes 614, 616. Insome configurations, the connector segment may trap moisture and/orinadvertently stick to the body. The holes 614, 616 can advantageouslyminimize the potential for undesired sticking or moisture collection.The size, shape and placement of the holes mitigate or reduce thecollection of moisture and/or undesired adhesive still providing aconnector with sufficient structural integrity (i.e. the connectorallows the flaps to be connected to one another in order to prevent themfrom folding). Additionally or alternatively, the connector holes couldalso be made to preferentially allow forces to be distributed alongcertain axes of the connector in order to further maximize the abilityof the device to adhere tong-term in the face of significant acute andchronic forces due to stretching, contraction, and torsion.

Adhesive can be selectively applied to the connector and/or naps toprovide the desired body attachment locations depending upon thespecific use of the device. For example, one piece of material includingflaps and the connector can be adhered along two or more edges and/orwith adhesive only covering certain areas, In another aspect, at least aportion of the skin-contacting surface of the unitary nap connectorstructure does not include any adhesive. Additionally or alternatively,the connector segment incorporating the flaps may be integral parts ofthe larger device housing (e.g. could be molded as part of the devicehousing or enclosure).

In some embodiments, the patch 100 can include one or more releaseliners to cover parts of the adhesive prior to adhesion. As isparticular to devices having multiple adhesive areas and/or multipleadhesive components (i.e., flaps and flexible sections), the manner ofapplying the device may be specifically detailed in order to ensure thatthe device and the adhesive portions are properly engaged. In oneparticular aspect, the release liners are removed in a particular orderto minimize the likelihood that the device adhesive is misapplied. Forexample, a portion of the adhesive may be exposed first and used toaffix the device to the body, Thereafter, a second set of adhesiveliners may be removed to expose and affix one or more flaps to the body,A stepwise adhesive exposure method may be implemented during deviceapplication such that elements, such as the one or more flaps do notfold on themselves, for example.

Breaking up the areas in which the adhesive is used to adhere thedevice, whether it be splitting it up to rigid areas, to create flaps,to create connector segments with holes, of any of the other techniquesdescribed above may also have benefits in terms of preventing moisturebridges that could act as conducting pathways between electrical sensingelements, such as electrodes. Bridges of moisture could short-circuitelectrical connections and/or prevent the proper functioning of thedevice, particularly if the device has an electrical function, such assensing via electrodes.

In some applications, a long-duration patch may experience excessiveforces due to acute (quick and/or rapid) or chronic (slow and/orprolonged) contraction, stretching, or torsion. In such applications,the hinge points between a floating rigid section and flexible adheredsections may be modified in order to align with and counteract ormitigate the predominant direction of the force acting on the patch. Insome device situations or configurations, the strength and direction ofthe acute or chronic force may be so strong that the forces imparted onthe device adhesive surfaces or components may be distributeddifferently in addition to or as an alternative to the hinge describedabove.

Further, the device construction can be made in such a way that thehousing is fashioned so that the axes of the housing are structured andplaced along or against the direction of various forces, possibly duringcertain states, such as sleeping, so that the device itself can helpcounteract these forces and improve long-term adhesion.

Advantageously, the patch described herein can provide long-termadhesion to the skin. Having the various flexible portions and/or hingedportions can compensate for stressed caused as the skin stretches orbends, while allowing the rigid portion to float about the skin. As aresult, the devices described herein can adhere to the skinsubstantially continuously tor more than 24 hours, such as greater than3 days, for example, greater than 7 days, greater than 14 days, orgreater than 21 days.

Another mechanism for adhering a patch to the skin long-term isdescribed with respect to FIGS. 7-10. As shown in the embodiments ofFIGS. 7-10, one or more parts of the patch are used in a temporaryfashion in order to improve adhesion. The adhesive used in theembodiments described below can include a hydrocolloid or apressure-sensitive adhesive, such as polyacrylate, polyisobutylenes, orpolysiloxane.

In one embodiment, shown in FIGS. 7A and 7B, the patch 700 can besurrounded with an adhesive 760 having multiple covers 701, 703, 705thereon that can be peeled away in a sequence to expose strips ofadhesive 760 underneath. The covers 701,703,705 can be concentric withone another and be configured to be pulled off separately andsequentially starting from the inside of the patch 700. Each additionalexposed area of adhesive 760 can increase the adhesion life of the patch700. Although only three covers are shown in FIG. 7 A, other numbers,such as 2, 4, 5, or more are possible. Further, each electrode 124, 126of the patch 700 can include a barrier 714,716 to protect the electrodes124, 126 from shortage.

In another embodiment, shown in FIGS. 8A and 8B, each electrode 124, 126can be surrounded by a patch of adhesive 864, 866. Accordingly, a set ofcovers 801, 803, 805, 807 can be positioned sequentially around each ofthe electrodes 124, 126 over the adhesive 864, 866. The covers 801, 803,805, 807 can be concentric with one another and be configured to bepulled off sequentially starting from the inside. Each additionalexposed strip of adhesive 864, 866 can increase the adhesion life of thepatch 100. Although only four covers are shown in FIG. 8A, othernumbers, such as 2, 3, 5, or more are possible. Further, each electrode124, 126 of the patch 800 can include a barrier 814, 816 to protect fromshortage.

Referring to FIGS. 9A-9B, in other embodiments, shells or layers901,902,903 can extend over all or a portion of the patch 900. Eachlayer 901, 902, 903 can include a strip of adhesive 962 on the bottomsurface and an adhesion guard 982 protecting the adhesive. As shown inFIG. 913, as the patch 900 is worn over a period of time, the layers901, 902, 903 can be sequentially removed. As a new layer is exposed,the adhesive guard 982 of that layer can be peeled away such that theadhesive 962 of the new layer can be used to adhere the patch 900 to theskin, In a similar embodiment, referring to FIGS. 10A-10B, each of thelayers 1001, 1002, 1003 can include multiple portions of adhesive tohelp adhere the layer to both the skin and the patch itself. As with theembodiments of FIGS. 7-8, the number of layers in the embodiments ofFIGS. 9 and 10 can vary. For example, there can be 2, 3, 4, or 5 or morelayers.

In some embodiments, the layers or covers of the embodiments describedherein can be added to the device over time to improve adhesion.Further, the multiple layers or covers of the embodiments describedherein can be partially overlapped. Further, in some embodiments, thestrips of adhesive can be overlapped.

Advantageously, the use of multiple covers or layers can assist in theadhesive performance of a base or core device because the added surfacearea or adhesive force of the combined outer layer aids in preventinglayer pull away and/or may act to spread forces being experienced awayfrom the core device by spreading those forces over a larger area.

Referring to FIGS. 11 and 12, an open cell structured support 1330 orporous foam can be used to support a more rigid or less flexible portion1302 of the patch 1300, As shown in FIG. 11, the open cell structuredsupport 1330 can fully fill an area below the rigid portion 1302.Alternatively, as shown in FIG. 12, the open cell structured support1330 can be an annular shape or have some other configuration thatincludes spaces between adjacent portions of the support. The open cellstructured support 1302 may be attached to both the skin and to therigid portion, to only the rigid portion, or to only the skin. Becauseof the open cell structure of the support, the flexible movement of theskin can be absorbed by the structure entirely or partially such thatthe rigid portion does not impact or has a reduced impact on the abilityof the device to accommodate movement and remain affixed. In addition,the open cell support may have a thickness selected to enhance patientcomfort so that the more rigid portion of a device does not push againstthe skin. In one aspect, the open cell structure is a biocompatible foammaterial. In another aspect, the open cell material is positionedbetween an electronics module on the device and the skin when worn by apatient. The open cell support can advantageously absorb fluids to keepthe electrodes from shorting.

Referring to FIG. 13, the patch can have a shell design. Adhesive can beplaced on the perimeter edge of the bottom ring. The circuit board andelectrode unit can be dropped into the bottom ring, and a shell can bedropped on top of the circuit board and electrode. The perimeteradhesive can create a watertight chamber therein.

The shape of a particular electronic device embodiment may vary. Theshape, footprint, perimeter or boundary of the device may be a circle orcircular (see FIG. 13A), an oval (see FIGS. 1A, 2A), a triangle orgenerally triangular (see FIG. 1F) or a compound curve. Examples of adevice embodiments having a compound curve shape are shown in FIGS. 2B,2B, 3, 6A, 7A, and 8A. In some embodiments, the compound curve includesone or more concave curves and one or more convex curves. FIG. 3illustrates a device having a convex surface along the top (wherereference 102 indicates), a concave surface along the bottom and convexshaped edges around the electrodes 124, 126. FIGS. 2B and 2C illustratea device embodiment having a convex shape on either side of theelectronics 108 and around the electrodes 124, 126. The convex shapesare separated by a concave portion. The concave portion is between theconvex portion on the electronics and the convex portion on theelectrodes, In some embodiments, the concave portion corresponds atleast partially with a hinge, hinge region or area of reduced.

While described in the context of a heart monitor, the device adhesionimprovements described herein are not so limited. The improvementdescribed in this application may be applied to any of a wide variety ofconventional physiological data monitoring, recording and/ortransmitting devices. The improved adhesion design features may also heapplied to conventional devices useful in the electronically controlledand/or time released delivery of pharmacological agents or bloodtesting, such as glucose monitors or other blood testing devices. Assuch, the description, characteristics and functionality of thecomponents described herein may be modified as needed to include thespecific components of a particular application such as electronics,antenna, power supplies or charging connections, data ports orconnections for down loading or off loading information from the device,adding or offloading fluids from the device, monitoring or sensingelements such as electrodes, probes or sensors or any other component orcomponents needed in the device specific function. In addition oralternatively, devices described herein may be used to detect, record,or transmit signals or information related to signals generated by abody including but not limited to one or more of EKG, EEG, and/or EMG.

1-45. (canceled)
 46. An electronic device for long-term adhesion to auser, the device comprising: a housing comprising a physiologic datacollection circuit, the housing positioned over a flexible layerextending from the housing, the flexible layer comprising an electrodepositioned on the bottom of the flexible layer at a position distal fromthe housing; an adhesive layer positioned on the flexible layer andconfigured to adhere the electronic device to a user, the adhesive layerextending at least partially below the housing; and wherein the housingis configured to tilt at an angle relative to the adhesive layer inresponse to movement of the user.
 47. The electronic device of claim 46,wherein the adhesive layer extends at least partially below the housing.48. The electronic device of claim 46, further comprising a flapextending beneath the housing.
 49. The electronic device of claim 46,wherein the housing is rigid.
 50. The electronic device of claim 46,wherein the housing is configured to remain connected to the flexiblelayer when the housing is tilted at an angle relative the adhesive layerin response to movement of the user.
 51. The electronic device of claim46, further comprising a hinge portion adjacent the housing.
 52. Theelectronic device of claim 46, wherein the adhesive layer comprises ahydrocolloid adhesive.
 53. The electronic device of claim 46, furthercomprising a synthetic material layer positioned above the adhesivelayer.
 54. The electronic device of claim 46, wherein the physiologicdata collection circuit is configured to collect cardiac rhythm datafrom the user.